Canadian clinical trial registry

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Study Description

This study is to evaluate the drug called BMS-986158 as a possible treatment for pediatric solid tumors, lymphoma, or brain tumors. BMS-986158 belongs to a group of drugs called "Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors". These drugs block proteins from the BET family that are important in reading part of the DNA involved in apoptosis and cell cycle progression. It is expected to slow or stop the growth of cancer cells.

The aim of this phase I study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of BMS-986158 in children with refractory or relapsed pediatric solid tumors, lymphoma, or brain tumors for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

Inclusion Criteria

• Age ≤ 21 years at time of enrollment.
• All patients must be able to swallow intact capsules.

• Participants must have evaluable or measurable disease and must have disease that is relapsed or refractory and for which standard curative measures do not exist or are no longer effective.

• Disease genetic alterations: MYCN amplification or high copy number gain, translocation involving MYC or MYCN, translocation involving BRD4 or BRD3

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This is a Phase 1 clinical trial designed to study a drug called 23ME-00610 in children and adults with advanced solid tumors that have not responded to or gotten worse after stardard therapy, or where no further standard therapy exists. In Part A of this study, researchers are looking to find the best possible dose of 23ME-00610 (called the recommended phase 2 dose). Part B of this study will evaluate how the patients body responds to the drug 23ME-00610 and continue monitoring safety. 

Inclusion Criteria

• To enroll in Part B of the study, the patient must be  ≥ 12 years of age
• Patient must weigh at least 40kg
• Patient must have a solid tumor:
  • that has progressed after all available standard therapy
  • or for which standard therapy has been ineffective
  • or for which no standard therapy exists
• Patient is up and about for at least half of their waking hours 
• Patient must have a solid tumor that has not previously been exposed to radiation

Additional inclusion or exclusion criteria may apply and will be discussed with you by the study team 

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Study Description

This study is to find the appropriate dose as well as to assess the safety and effectiveness of a drug called quizartinib for children with relapsed or refractory acute myeloid leukemia (AML) with a certain mutation called FLT3-ITD. Quizartinib is a drug designed to specifically block the FLT3 protein when it is abnormal in a leukemia cell.

Inclusion Criteria

• Children 1 month to 21 years of age
• Acute myeloid leukemia that has come back or is not responding to current treatment
• Presence of the FLT3-ITD mutation in the leukemia
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This study will assess the molecular subtype (abbreviated WNT, SHH, Non-WNT, Non-SHH) of patients with medulloblastoma. Based on the subtype And other factors, patients will be assigned to a "risk group", each risk group receiving specific treatment with chemotherapy and radiation therapy.

Patients with a specific molecular subtype called Sonic Hedgehog (SHH) will be treated with a medication taken by mouth, called vismodegib in addition to standard therapy, to directly target the molecular pathway. 

Inclusion Criteria

• Patients between 3 and 22 years of age with medulloblastoma.
• Patients between 22 and 40 years with medulloblastoma of the SHH subtype are eligible.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This study seeks to test the safety and effectiveness of the drug taken by mouth called idasanutlin when taken together with chemotherapy or other cancer drugs (venetoclax) to treat acute leukemias or solid tumors in pediatric or young adults. 

The study is divided into 3 parts. The first part of the study aims to figure out the maximum dose of idasanutlin that can be safely tolerated as well as the recommended dose of idasanutlin when used in combination with chemotherapy and other cancer drugs (venetoclax).

The second part of the study aims to test the safety and effectiveness of idasanutlin in combination with chemotherapy and other cancer drugs (venetoclax) for treating neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).

The third part of the study further monitors patients for additional responses to idasanutlin and safety assessments.

Inclusion Criteria

• Age less than 18 years old or less than 30 years old depending on study groups
• Diagnosis of neuroblastoma, acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) that has worsened or come back despite the use of standard therapy.
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

The purpose of this study is to test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

• Age <12 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

• Age 12 to less than 25 years
• Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
• The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
• Some patients may be eligible even if they have already received another drug blocking NTRK in the past
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

In this study, researchers are trying to learn more about how safe the study medicine called Alectinib is, and how well they work for children and young people with certain solid or brain cancers where previous treatment has not worked or is not available.

Inclusion Criteria

• Patients must have a confirmed diagnosis of a brain tumour or solid tumor with a specific gene change called "ALK fusion"
• Patients must have a cancer that has come back (relapsed) or has no standard treatment available
• Patients must be 17 years old or younger to participate 
• Patients must be able to walk and do routine activities for more than half of their normal waking hours
• Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment.

Inclusion Criteria

• Participants must be ≤ 18 years of age (Part A and B only) or < 21 years of age (Part C only)
• Must have adequate body surface area (BSA)
• Participants must have a solid tumour (excluding lymphoma) that has come back or progressed on standard therapies
• PART C ONLY: Participants with neuroblastoma that has come back or progressed on standard therapies
• Participants must be able to be up and about for at least half of their waking hours
• Participants of reproductive potential must not be pregnant within 7 days of and during the study
• Ability to swallow
• Participants and their families (as applicable) must agree to the study assessments by signing an informed consent form

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team